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Brief Title: Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL)
Official Title: Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response.
Study ID: NCT03434158
Brief Summary: A number of important systemic therapies have been developed to treat mCRPC and have received regulatory approval and now comprise the current therapeutic landscape. Durable and complete response following first-line chemotherapy in patients with advanced PC are uncommon. Most patients will ultimately experience disease progression within 6-9 months after initial response. Optimal Second line therapy in mCRPC is not well established and several options are possible. Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene (gBRCA) mutated cancers including ovarian, breast, pancreas and prostate. Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival (rPFS) in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 1.1 criteria and PCWG3.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Complexo Hospitalario Universitario de Santiago, Santiago De Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
ICO L'Hospitalet, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Complejo Hospitalario Regional Reina Sofía, Córdoba, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Fundación Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Universitario i Politècnic La Fe, Valencia, , Spain
Name: María J Juan Fita, MD
Affiliation: Fundación Instituto Valenciano de Oncología
Role: PRINCIPAL_INVESTIGATOR